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BMJ Open. 2019 Jun 29;9(6):e027629. doi: 10.1136/bmjopen-2018-027629.

Clinical observations and a ealthcare ailure ode and ffect nalysis to identify vulnerabilities in the security and accounting of medications in Ontario hospitals: a study protocol.

Author information

HumanEra, Research and Innovation, North York General Hospital, Toronto, Ontario, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Institute for Safe Medication Practices Canada, Toronto, Ontario, Canada.



An increasing number of opioids and other controlled substances are being stolen from healthcare facilities, diverting medications from their intended medical use to be used or sold illicitly. Many incidents of medication loss from Canadian hospitals are reported as unexplained losses. Together, this suggests not only that vulnerabilities for diversion exist within current medication-use processes (MUPs), but that hospitals lack robust mechanisms to accurately track and account for discrepancies and loss in inventory. There is a paucity of primary research investigating vulnerabilities in the security and accounting of medications across hospital processes. The purpose of this study is to map hospital MUPs, systematically identify risks for diversion or unintentional loss and proactively assess opportunities for improvements to medication accounting and security.


We will conduct human factors-informed clinical observations and a Healthcare Failure Mode and Effect Analysis (HFMEA). We will observe hospital personnel in the intensive care unit, emergency department and inpatient pharmacy in two hospitals in Ontario, Canada. Observations will capture how participants complete tasks, as well as gather contextual information about the environment, technologies and processes. A multidisciplinary team will complete an HFMEA to map process flow diagrams for the MUPs in the observed clinical units, identify and prioritise potential methods of medication loss (failure modes) and describe mechanisms or actions to prevent, detect and trace medication loss.


We received province-wide research ethics approval via Clinical Trials Ontario Streamlined Research Review System, and site-specific approvals from each participating hospital. The results from this study will be presented at conferences and meetings, as well as published in peer-reviewed journals. The findings will be shared with hospitals; professional, regulatory and accreditation organisations; patient safety and healthcare quality organisations and equipment and drug manufacturers.


diversion; healthcare safety and quality; hospital medication use process; human factors

Conflict of interest statement

Competing interests: MDV, MF and PT have received honoraria from BD - Canada for presenting at BD-sponsored events. BD - Canada was not involved in study design or writing of this article, and will not be involved in the collection, analysis or interpretation of data; in the writing of the report or in the decision to submit the article for publication.

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